Multi-Lumen Indwelling Catheter

ABSTRACT

In one aspect, the present disclosure provides a catheter, the catheter with a distal length extending to a distal end, the distal length configured to indwell a cavity of a patient body. The distal length may include a first lumen extending longitudinally through a lengthwise portion of the distal length, where the first lumen may be at least partially defined by a first inner diameter surface of the distal length. The distal length may include a second lumen extending longitudinally through the lengthwise portion of the distal length, where the second lumen may be at least partially defined by a second inner diameter surface of the distal length. A first fenestration may be disposed through a side wall of the first lumen. A proximal length of the catheter may include a proximal lengthwise portion of the first lumen and the second lumen.

TECHNICAL FIELD

Embodiments of the present disclosure relate to methods and devices forperforming medical procedure involving a drainage function and/or aninjection function.

BACKGROUND

Chemotherapy generally refers to the use of medicines or drugs todestroy cancer cells. Typically, the chemotherapy drugs are deliveredvia intravenous methods or by taking capsules orally, therebydistributing the drug throughout the body. The toxic nature of the drugoften affects healthy cells as well as cancer cells, which can cause aseries of unpleasant side effects such as nausea, damage to the immunesystem, fatigue, and hair loss.

Recently, it has been found that cancer cells may be treated withlocalized application of chemotherapy drugs. For example, in oneprocedure called heated intraperitoneal chemoperfusion (“HIPEC”), warmedchemotherapy medication is circulated in the peritoneal cavityimmediately after the surgical removal of tumors. The chemotherapy drugsare then removed from the peritoneal cavity after a short time toprevent substantial damage to surrounding body tissue. While effective,HIPEC can only be performed after invasive surgical procedures grantingsufficient access to the body cavity. Because surgical procedures aretypically infrequent, repeat local application is usually not possiblesince access to the body cavity is generally limited in duration.

In view of this background, a medical device providing access to a bodycavity for the injection and drainage of a medication withoutsubstantial invasiveness would be advantageous.

BRIEF SUMMARY

In one aspect, the present disclosure provides a catheter, the catheterwith a distal length extending to a distal end, the distal lengthconfigured to indwell a cavity of a patient body. The distal length mayinclude a first lumen extending longitudinally through a lengthwiseportion of the distal length, where the first lumen may be at leastpartially defined by a first inner diameter surface of the distallength. The distal length may include a second lumen extendinglongitudinally through the lengthwise portion of the distal length,where the second lumen may be at least partially defined by a secondinner diameter surface of the distal length. A first fenestration may bedisposed through a side wall of the first lumen, where the firstfenestration may be configured to form an outlet of the first lumen. Aproximal length of the catheter may include a proximal lengthwiseportion of the first lumen and a proximal lengthwise portion of thesecond lumen. A cuff element may be disposed on an outer surface of theproximal length.

The proximal length may include a bifurcated length having a first tubeportion and a second tube portion, where the first lumen extendslongitudinally through the tube first portion, and where the secondlumen extends longitudinally through the second tube portion.

The first tube portion may include a first valve configured for aninjection procedure, and the second tube portion may include a secondvalve configured for a drainage procedure.

A distal end of the distal length may include the first lumen with aplurality of fenestrations spaced longitudinally, where the spacebetween the fenestrations decreases closer to a distal terminus.

A distal end of the distal length may include the first lumen with aplurality of fenestrations spaced longitudinally, where across-sectional size of the fenestrations increases closer to a distalterminus.

The distal length may include a distal bifurcated length having a firstdistal tube portion and a second distal tube portion, where the firstlumen extends through the first distal tube portion and the second lumenextends through the second distal tube portion.

A diameter of the second lumen may be at least two (2) times as large asa diameter of the first lumen.

The proximal length may include a first proximal tube portion with aninjection port.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a drainage apparatus as known in the prior art.

FIG. 2 shows an embodiment of a dual lumen indwelling catheter inaccordance with the present disclosure.

FIG. 3 shows a magnified view of the distal end of the dual lumenindwelling catheter of FIG. 2.

FIG. 4 shows an embodiment of a junction for a dual lumen indwellingcatheter in accordance with the present disclosure.

FIG. 5 shows a system with a dual lumen indwelling catheter and anintroducer in accordance with the present disclosure.

FIG. 6 shows a bottom view of four (4) embodiments of a distal end of adual lumen indwelling catheter with fenestrations in accordance with thepresent disclosure.

FIG. 7 shows an illustration of the flow of a substance as it isinjected by a lumen of a dual lumen indwelling catheter in accordancewith the present disclosure.

FIG. 8 shows an illustration of the flow of a substance as it isinjected by a lumen of a second embodiment of a dual lumen indwellingcatheter in accordance with the present disclosure.

FIG. 9 shows an illustration of the flow of a substance as it isinjected by a lumen of a third embodiment of a dual lumen indwellingcatheter in accordance with the present disclosure.

FIG. 10 shows an embodiment of a distal end of a dual lumen catheterwith offset fenestrations in accordance with the present disclosure.

FIG. 11 shows embodiments of tips of a dual lumen indwelling catheter inaccordance with the present disclosure.

FIG. 12 shows an embodiment of a dual lumen indwelling catheter with aport in accordance with the present disclosure.

FIG. 13 shows a distal end of an embodiment of a catheter withbifurcated distal length having separated distal tube portions inaccordance with the present disclosure.

FIG. 14 shows an embodiment of a dual lumen indwelling catheter with abifurcated distal length in accordance with the present disclosure.

FIG. 15 shows an embodiment of a dual lumen indwelling catheter with abifurcated distal length and including a port in accordance with thepresent disclosure.

FIG. 16 shows an embodiment of a dual lumen indwelling catheter with acirculating pump in accordance with the present disclosure.

FIGS. 17A-B show two embodiments of a dual lumen indwelling catheterdeployed in a peritoneal cavity and an organ, respectively, inaccordance with the present disclosure.

FIG. 18 shows an embodiment of a dual lumen indwelling catheter withseparable tube portions and variable tube portion lengths in accordancewith the present disclosure.

DETAILED DESCRIPTION

Embodiments generally are described with reference to the drawings inwhich like elements are generally referred to by like numerals. Therelationship and functioning of the various elements of the embodimentsmay better be understood by reference to the following detaileddescription. However, embodiments are not limited to those illustratedin the drawings. It should be understood that the drawings are notnecessarily to scale (including that relative lengths and otherproportions may be the same as or different than various illustrationsherein), and in certain instances details may have been omitted that arenot necessary for an understanding of embodiments of the presentinvention, such as—for example—conventional fabrication and assembly.

Medical drainage procedures may be performed with drainage devices ofthe type shown in FIG. 1. The apparatus 100 is shown as installed in apatient body and includes a drainage container 114. The drainagecontainer 114 is removably attached by a proximal tube 110 at a valve 60to a distal catheter 12. The valve 60 may be configured in any number ofways known in the art for attaching catheters together in a fluid-patentmanner, (which may include a two-part valve), and the proximal portionattached to the distal catheter 12 may be configured to be self-sealingwhen disconnected from the proximal tube 110. The proximal end portionof the distal catheter 12 is shown indwelling the patient, disposedthrough the body wall 21 into an intra-body space 23, which may be—forexample—a pleural, peritoneal, or other body lumen. That proximalportion includes a cuff element 19 and a flexible fluid-intake length 14including fenestrations 18, shown in the intra-body space 23. Thisstructure may be better understood with reference to U.S. Pat. No.5,484,401, which is herein incorporated by reference in its entirety,and with reference to commercial products marketed under the namePleurX® by CareFusion® of San Diego, Calif. Another structure that maybe useful for providing such a method is disclosed in U.S. App. Pub. No.2015/0174375 to DeVries et al., which is herein incorporated byreference in its entirety and with reference to commercial productsmarketed under the name PleurX® by CareFusion® of San Diego, Calif.

It would additionally be advantageous to provide a single indwellingcatheter that can perform the above-described drainage function, butalso can deliver a drug to a body cavity without substantiallyincreasing the invasiveness of the device. FIG. 2 shows an embodiment ofa dual lumen indwelling catheter, depicted as the catheter 200, whichmay be configured to indwell a body trunk cavity that provides one orboth of a drainage function and an injection function, includingseriatim or simultaneously. The catheter 200 may be a siliconemulti-lumen catheter for long term pleural access to administermedication and drain fluid (i.e., drug and effusion). The catheter 200may allow for a patient to perform drainage and drug administration athome and/or allow for multiple treatments over time with minimalinconvenience to the patient. This device can be used to, among otherthings, deliver therapy for malignant or benign conditions includingpulmonary fibrosis and malignant mesothelioma, and cancers with lungmetastases.

The catheter 200 is depicted with two lumens: a first lumen 202 and asecond lumen 204. The first lumen 202 and the second lumen 204 mayextend longitudinally through at least a lengthwise portion of abifurcated length 206 and a binal portion 214. The first lumen 202 andthe second lumen 204 may be configured for particular functions. Forexample, the first lumen 202 may be configured primarily for thedelivery of a substance (e.g., a medication for effecting pleurodesis ora medication for treating cancer) to a target area within the body of apatient, while the second lumen 204 may be configured primarily for adrainage procedure. While not shown, it is contemplated that more thantwo lumens may be included. The two lumens (in a binal embodiment) mostpreferably are parallel for their entire respective lengths and are notcoaxial along any lengthwise portion, although one or both may have anon-circular cross-section and partially surround the other. However,one preferred embodiment includes two lumens along the binal portionthat each have a circular cross-section, and that are parallel to eachother and a longitudinal central axis of the binal portion.

The proximal end of the catheter 200 may include the bifurcated length206 with a first tube portion 208 and a second tube portion 210. Thefirst lumen 202 may extend through the first tube portion 208 and thesecond lumen 204 may extend through the second tube portion 210, asshown. In at least one exemplary embodiment, the first tube portion 208and the second tube portion 210 may be about 4 inches in length (but anysuitable length may be used). The length of the first tube portion 208and the second tube portion 210 may be substantially the same ordifferent. The first tube portion 208 and the second tube portion 210may join at a junction 212. The binal portion 214, which may be made ofa flexible silicone providing patient comfort, may extend distally fromthe junction 212, and may include the two lumens 202, 204 extendinglongitudinally therethrough. The binal portion 214 may be a flexibletube-like structure with two inner diameter surfaces substantiallydefining side walls of at least a portion of the two lumens 202, 204.The binal portion 214 of the catheter 200 may have any suitable length(such as approximately 16 inches in at least one exemplary embodiment).A distal length 220 of the binal portion 214 may be configured to beplaced in the body of a patient temporarily or permanently (for example,for a time period of about 6-8 weeks in a non-limiting exemplaryembodiment). Herein, the distal length 220 may be the length of thebinal portion 214 that is designed for entry into a patient body, whilea so-called proximal length may be the length of the catheter 200(including both a length of the binal portion 214 and the bifurcatedlength 206) that generally remains external to the patient body.

The first tube portion 208 and/or the second tube portion 210 may beassociated with a valve (or port) 216, 218. It is contemplated that thevalves 216, 218 may be configured for the particular function of theirassociated lumens. For example, the first tube portion 208 may includethe first valve 216 which may be configured for the delivery of amedication or another substance. Exemplary valves include Texium® andSmartsite® valves marketed by CareFusion® of San Diego, Calif. The firstvalve 216 may be associated with a suitable injection system, suchas—for example—a syringe, a pressurized injector, a pump, or any otherappropriate means for injection. It is contemplated that the first valve216 may be designed to be operable (i.e., openable) only by a medicalprofessional and/or only with corresponding equipment generallyavailable only at a medical facility, which may prevent inadvertent andimproper access by a patient.

The second tube portion 210 may include a second valve 218, which may beconfigured for a drainage procedure. An exemplary second valve 218 maybe a valve marketed under the name PleurX® by CareFusion®, and may bedesigned for use with drainage equipment, such as vacuum bottles andother suction devices, drainage bags, or the like. It is contemplatedthat the second valve 218 may be operable by the patient without thepresence of a medical professional. Advantageously, the describedembodiment of the catheter 200 having the first valve 216 and the secondvalve 218 may simultaneously provide the ability for (1) a medicalprofessional to inject a medication into a patient as needed with afirst lumen 202 without risk of the patient inadvertently or improperlyaccessing the first lumen 202 and (2) the patient to access the secondlumen 204 for drainage purposes without the presence of the medicalprofessional. The valves 216, 218 and/or the tube portions 208, 210 maybe individually marked for ease of identification.

A cuff element 222 may be located at the proximal end of the distallength 220. The cuff element 222 may be provided on the outer surface ofthe binal portion 214. When installed, at least the outer diametersurface of the cuff element 222 may contact the skin or other tissue(such as the tissue surface of an incision) at or near the locationwhere the catheter 200 enters the body. In some embodiments, forexample, the cuff element 222 may be tunneled into the body about 1 cmpast the incision, and it is contemplated that the cuff element 222 maynot be exposed outside the body. The cuff element 222 may be textured orotherwise configured to allow and facilitate tissue ingrowth. Over time,the skin or other tissue of the patient may become secured to the cuffelement 222, and the cuff element 222 may provide a seal betweeninternal and external of the patient's body, thereby reducing the riskof infection and other medical complications. In other words, the cuffelement 222 may become part of a sealed barrier continuous andcontiguous with the rest of the patient's skin as an integrated part ofhis/her natural epidermal barrier. The cuff element 222 may be made ofDacron™ or another suitable material. The cuff element 222 mayincorporate an adhesive or another suitable means for attachment/sealingto be used in combination with, or as an alternative to, tissueingrowth. It is contemplated that a location immediately adjacent thecuff may include a microtextured surface that may inhibit microbialcolonization and migration in/toward the patient's body as described inU.S. patent application Ser. No. 15/169,410 to Krueger et al., which isherein incorporated by reference in its entirety.

The binal portion 214 may be formed of a flexible and biocompatiblematerial suitable for deployment in a body trunk cavity. In someembodiments, the binal portion 214 may include a memory-materialconfigured to guide at least the distal end of the catheter 200 to atarget location in a patient body. The memory material may include anyappropriate metallic or polymeric material upon which shape-memory maybe imposed, while allowing flexibility. For example, various nitinol andother memory metal compounds are well-known and commonly used in themedical device art. Other materials can receive and default-return to ashape (imposed by mechanical, temperature, and/or other means) afterflexure into different shape(s). The memory configuration may be assumedbased upon temperature, release of constraint, and/or by active means.The binal portion 214 may additionally or alternatively include one ormore one visualization markers 215 configured to be visualizable in apatient body by at least one of fluoroscopy, ultrasound, magneticresonance imaging, and computed tomography, or another suitabletechnology. The visualization marker(s) may assist medical personnelduring deployment of the catheter 200, for example.

The lumens 202, 204 may have any suitable cross-sectional size. Forexample, when the lumens 202, 204 have circular cross-sections (see FIG.3), the diameter of the lumens 202, 204 may be between about 0.005inches and about 1 inch, such as from about 0.030 to about 0.300 inches.As best shown by FIG. 3, the first lumen 202 and the second lumen 204may have different cross-sectional dimensions. For example, the diameterof the first lumen 202 may be a diameter suitable for a relativelyprecise injection procedure (such as a diameter of about 0.050 inches),and the diameter of the second lumen 204 may be suitable for theperformance of a relatively less-precise drainage procedure (such asabout 0.100 inches). The diameter (or other cross-sectional dimension)of the second lumen 204 may be about 1.5 times larger than the diameter(or other cross-sectional dimension) of the first lumen 202, about 2times larger, about 3 times larger, about 4 times larger, etc. In oneexemplary embodiment, the diameter of the first lumen 202 may be about0.044 inches (and the outer diameter of the tube forming the first lumen202 may be about 0.063 inches), and the diameter of the second lumen 204may be about 0.095 inches (and the outer diameter of the tube formingthe second lumen 204 may be about 0.200 inches), which may provide adesirable flow rate and wall thickness in certain medical applications.

FIG. 4 shows an embodiment of the junction 212 in detail. The junction212 may be a separate component from tubing forming the bifurcatedlength 206 and/or the binal portion 214 (e.g., it may be a componentformed separately from, and then attached to, the first tube portion208, the second proximal tube 210, and/or the binal portion 214). Insome embodiments, the binal portion 214 may merely be a point where twotubes are connected to one another at a contact point (through use of anadhesive, through fusing, etc.) (see FIG. 2). The junction 212 and/orthe binal portion 214 may be ovular in cross-section, as shown, but thisis not required. However, it may be advantageous to use an ovularcross-section when two lumens 202, 204 are provided due to therelatively small surface area and relatively smooth and continuousouter-perimeter shape. While not shown, the junction may include avisual indicator, such as a barium stripe.

Referring to FIG. 5, in some embodiments, the binal portion 214 may besized or otherwise configured to be directed through an introducer 224,which may include a pinch valve 226 as shown. For example, the outerperimeter of the binal portion 214 may be configured (e.g., dimensioned)to fit within a channel of a commercially-available introducer 224.Advantageously, the valved introducer 224 may control both lumens 202,204 at the same time, which may be desirable when a medical functionrequires synchronized function of the lumens 202, 204, for example. Theintroducer 224 may be configured as a commercially available splittableintroducer of any type already known in the art for introduction of atubular device through a body wall or other structure, followed bysubsequent removal of the introducer circumferentially encompassing theintroduced device.

FIG. 6 shows a bottom view of four embodiments of a distal end of a duallumen indwelling catheter 300 with fenestrations 326 through the sidewall of at least one lumen. The fenestrations 326 may serve as an inletand/or an outlet for one or more lumens of the catheter 300, such as aninjection lumen (e.g., the first lumen 202 of FIG. 1-FIG. 2) and/or adrainage lumen (e.g., the second lumen 204 of FIG. 1-FIG. 2). In someembodiments, the fenestrations 326 may serve as the only inlet oroutlet, but in other embodiments an opening may be provided at thedistal terminus 328 of the catheter 300 (as shown in FIG. 2, forexample). As shown in embodiment A of FIG. 6, the fenestrations 326 maybe spaced apart with approximate consistency along the length of thedistal end of the catheter 300. Also, as depicted, the fenestrations 326may be elliptical rather than circular in cross-section, though noparticular shape is required in the present disclosure. Each of thefenestrations may be about the same size, as shown. The fenestrationsmay also have valve-type configuration(s) that render them effectivelyone-way for inlet or outlet functionality.

A catheter 400 may have fenestrations 426 with an unequal spacing, asdepicted by embodiment B. For example, as shown, the space between eachof the fenestrations 426 may decrease nearer a distal terminus 428.

Advantageously, this embodiment may provide a relatively evendistribution of medication when the fenestrations 426 are associatedwith an injection lumen. The advantageous characteristics of thisembodiment are discussed in more detail with respect to FIG. 7 below.

Referring to embodiment C, the size of two or more fenestrations 526 mayvary along the length of a catheter 500. For example and as shown, thesize of the fenestrations 526 may increase nearer a distal terminus 528.Similar as to in embodiment B, this embodiment may provide a relativelyeven distribution of medication when the fenestrations 526 areassociated with an injection lumen, which is described in more detailbelow with respect to FIG. 7.

As represented by embodiment D of FIG. 6, a catheter 600 may havefenestrations 626 with a cross-sectional shape that acts as a nozzle.Advantageously, the nozzle-like fenestrations 626 may inject amedication or other substance into the body of a patient with arelatively high velocity and may focus the flow of the medicationprecisely on a target location within the patient body. The nozzle-likefenestrations 626 may be any suitable shape and size. Further, two ormore of the shape, size, and spacing characteristics described hereincan be combined in any suitable manner to optimize the catheter 600 fora particular function.

FIG. 7 shows an illustration of the flow of a medication (e.g., amedicament or other substance) as it is injected into the body of apatient by a first lumen 702 of a catheter 700. Medications dispensablethrough the first lumen 702 may include sclerosis-inducing agent(s),therapeutic agent(s), chemotherapy agent(s), gene therapy agent(s),and/or other materials. Medications may be configured as liquids,solutions, suspensions, gels, pastes, or any combination thereof and mayinclude effervescent material (e.g., sodium bicarbonate and citric acidor other combination that can be activated by temperature,liquid-contact, or other means) configured to aid dispersion through thebody cavity by formation of bubbles and/or spreading by similar means.Examples of medications may include talc, silver nitrate, bleomycin,and/or other sclerosis-inducing agents. In addition or in thealternative, examples of medicaments may include chemotherapy agents,antibiotic(s), loculation-breakup compound(s) (e.g., tissue plasminogenactivator tPA), and/or other materials. A biologic fluid (e.g., apatient's own blood, immunotherapy, or other biologic agent) may beeffective to provide or enhance therapeutic treatment of a pleuraleffusion or other condition being treated with a method and/or apparatusof the present disclosure, and may therefore be considered as amedication herein.

The catheter 700 may include the first lumen 702 with the fenestrations726 and a second lumen 704 (which may also include fenestrations thatare not shown). Each of the fenestrations 726 may be about the samesize, and the spacing between each of the fenestrations 726 may be aboutthe same. As shown, due to the physics of fluid flow as the fluid 730moves distally through the lumen 702, the fluid 730 may experience atotal pressure loss due to (1) a friction-related pressure drop and (2)a loss of pressure corresponding to a flow-rate out of the lumen 702 ateach outlet (i.e., each fenestration 726). Accordingly, the injectionpressure (herein defined as the pressure of the fluid 730 in the lumen702 just before it discharges from a fenestration 726) of the fluid 730will decrease with respect to each distally-successive fenestration 726.As a result, the fluid may be injected into a patient at a decreasingflow rate with respect to each distally-successive fenestration 726.This embodiment may be advantageous where it is desired to vary the flowrate of a medication at different locations within a patient body.

FIG. 8 shows an illustration of an injection procedure by a secondembodiment of a catheter 800 with first and second lumens 802, 804. Thecatheter 800 is depicted as having features similar to the catheter 700of FIG. 7, but with decreasing spacing between the fenestrations 826with respect to the distal direction. In this embodiment, the injectionpressure of the medication 830 may be more consistent along the lengthof the catheter 800 such that the medication 830 is released relativelyevenly (i.e., the flow rate out of each of the fenestrations 826 variesless). Advantageously, this embodiment may provide for a more consistentapplication of the medication at a treatment site within a patient body.

FIG. 9 shows a similar effect may be achieved by increasing the size ofeach distally-successive fenestration of a catheter (for example, asshown by embodiment C of FIG. 6). A catheter 900 (with lumens 902, 904)may include fenestrations 926 that increase in size distally. In thisembodiment, while the injection pressure will decrease a relatively highamount with respect to distally-successive fenestrations when comparedto the embodiment of FIG. 8, the flow rate of the medication 930 out ofa fenestration is a function of both (1) the injection pressure, and (2)the size (and shape) of the fenestration. Accordingly, largerfenestrations will provide for a higher injection flow rate. The size ofeach of the fenestrations can be optimized such that the flow rate isrelatively consistent along the length of the catheter to therebyadvantageously provide even distribution of the medication at atreatment site. It is contemplated that the fenestrations 926 may bedesigned to purposely vary the injection flow rate along the length ofthe catheter to vary the distribution of the medication in a controlledmanner.

While the characteristics related to variations in size and spacing andshape are illustrated in isolation, a catheter may have fenestrationswith a combination of varying size and varying spacing to achieve adesirable distribution of an injected medication. In addition, more thanone lumen of the catheter may incorporate these describedcharacteristics related to fenestrations. For example, referring to thecatheter 200 of FIG. 2, one or both of the first lumen 202 and thesecond lumen 204 may incorporate fenestrations having different sizesand different spaces therebetween.

Further, as depicted by the embodiment of FIG. 10, a catheter 1000 mayinclude fenestrations 1026, 1027 that are offset with respect to thelongitudinal direction of the catheter 1000. This feature may becombined with any of the other fenestration-related characteristicsdescribed above. Advantageously, a medication may be injectedconsistently with respect to the radial direction to further enhance thedistribution of a medication. While advantages of the herein-describedfenestration-related characteristics are primarily described withreference to injecting a substance, those same advantages (or similaradvantages) may also apply with respect to a drainage procedure.

In addition to, or as an alternative to, the fenestrations describedabove, one or more lumens of a catheter may include a distal endconfigured for a particular distribution of an injected medication(and/or drainage). Referring to embodiment E of FIG. 11, the distal end1132 may include a tapered tip configured to act as a nozzle to inject amedication or other substance with a high velocity and high focus in thelongitudinal direction. As shown by embodiment B, the distal end 1232may include a plurality of extremities 1234, where each of theextremities 1234 includes at least one outlet such that the medicationis injected in many different directions. It is contemplated that theextremities 1234 may be flexible, and they may be protected by aremovable sheath (not shown) during the deployment of the catheter, forexample. A balloon tip 1334 with a plurality of outlets may be includedon the distal end 1332 as shown by embodiment C. The balloon tip 1334may be in fluid communication with at least one lumen of the catheter,and may expand when under pressure (e.g., when an injection pressure ispresent).

FIG. 12 shows an embodiment of a catheter 1400, which may be a duallumen indwelling catheter similar to the catheter 200 of FIG. 2, butwith a port 1450. The port 1450 may be a medical appliance that isdeployed beneath the skin of a patient with a septum or other membranethrough which can be injected. The septum may be located near thesurface of the skin of the patient such that a needle can penetrate theskin and the septum to access a cavity of the port 1450. The cavity ofthe port 1450 may be in fluid communication with an injection lumen ofthe catheter 1400 such that the port 1450 provides an interface betweena medical professional and the injection lumen of the catheter 1400. Theinjection lumen of the catheter 1400 may direct the injected medicationor other substance from the port 1450 to a target location within thepatient body as described in detail above. A cuff element 1422 may beincluded proximal to a junction 1412, as shown. It is also contemplatedthat the cuff element 1422 could be distal to the junction 1412.Embodiments with a port are described in more detail below.

FIG. 13 shows a distal end of a catheter 1500 with a bifurcated distallength having separated distal tube portions depicted as the firstdistal tube portion 1540 and the second distal tube portion 1542. Thedistal tube portions may be formed of a flexible silicone to providepatient comfort and in some embodiments may include a memory materialfor deployment to a specific area of a body cavity. The first distaltube portion 1540 and the second distal tube portion 1542 may extendfrom a binal portion 1514. A first lumen 1502, which may be an injectionlumen, may extend through the binal portion 1514 and the first distaltube portion 1540. Similarly, the second lumen 1504, which may be adrainage lumen, may extend through the binal portion 1514 and the seconddistal tube portion 1542. The depicted bifurcated distal length of FIG.13 may be combined with any of the embodiments disclosed herein.

For example, FIG. 14 shows a catheter 1600 having a bifurcated distallength with a first distal tube portion 1640 and a second distal tubeportion 1642. The bifurcated distal length may be configured fordeployment within a body cavity, such as the pleural space 1660surrounding a lung 1662. The catheter 1600 also has a bifurcatedproximal length with a first proximal tube portion 1608 and a secondproximal tube portion 1610. The first proximal tube portion 1608 mayinclude a first lumen, which may extend from the first proximal tubeportion 1608, through a binal portion 1614, and to the first distal tubeportion 1640. The first lumen may be an injection lumen similar to asdescribed above, and the first distal tube portion 1640 may include adistal end with fenestrations for providing a particular distribution ofan injected medication (e.g., the fenestrations of FIGS. 7-10 and/or theend features of FIG. 11). A first valve 1616 may provide access to thefirst lumen. The second lumen may be a drainage lumen similar to asdescribed above, and the second distal tube portion 1642 may includefenestrations and/or other end features configured for drainage. Asecond valve 1618, which may be a different valve than the first valve1616, may provide access to the second lumen. A cuff element 1622 may beincluded on the binal portion 1614 (or another portion) and may beconfigured for facilitating tissue ingrowth, as described above.

The embodiment of FIG. 14 may be advantageous for providing a lavageprocess of circulating a fluid through a body cavity. For example, afluid medication or other fluid may be injected into an injection lumenat the first proximal tube portion 1608 through the first valve 1616.The fluid may the travel through the injection lumen of the catheter1600 to a distal end of the first distal tube portion 1640, where it isinjected into the depicted pleural space 1660. The first distal tubeportion 1640 may be maneuvered in the pleural space during installationsuch that it is located at a relatively high location with respect tothe second distal tube portion 1642. As such, the fluid may be pulled atleast partially by the force of gravity through the pleural space 1660to a respectively lower location (making contact with, and/or travelingthrough, the lung 1662, on its way). The second distal tube portion 1642may be located at that relatively lower location to drain and remove thefluid from the pleural space 1660. It is contemplated that drainagelumen of the second distal tube portion 1642 may provide a suction forceto facilitate the flow of the fluid. The fluid may then be pulledthrough the drainage lumen and exit the catheter 1600 at the secondproximal tube portion 1610 through the second valve 1618. As describedin more detail above (with reference to FIG. 2), the first and secondvalves may be different valve models configured for their particularfunction (e.g., drainage or injection).

FIG. 15 shows an embodiment of a catheter 1700 similar to the catheter1600 of FIG. 14, but including a port 1750. The port 1750 may be locatedbeneath the outer surface 1764 of the skin of a patient, and may providean interface between a medical professional and a lumen (e.g., aninjection lumen) of the catheter 1700. The port 1750 may be located on afirst proximal tube portion 1708 associated with the injection lumen. Aneedle or other device (not shown) may be used to penetrate the skin anda septum of the port 1750 to inject a fluid into the port 1750, whichmay then flow to a distal end of the first distal tube portion 1740. Thefluid may then move through the body cavity and be drained through thesecond distal tube portion 1742 and circulated back out of the catheter1700 through the valve 1718.

This embodiment may be advantageous for concealing at least one of theproximal tube portions (in this case, the first proximal tube portion1708). Further, it may ensure the first proximal tube portion 1708 isnot confused with the second proximal tube portion 1710 and/or mayensure the injection lumen of the first proximal tube portion 1708remains relatively inaccessible to the patient. The second proximal tubeportion 1710 may remain accessible to the patient, and may be used inisolation by a medical professional, the patient, or another person toperform a drainage procedure separate from a lavage process. It is alsocontemplated that the port 1750 may be utilized during an injectionprocedure separate from a lavage process.

Another embodiment of a dual lumen catheter 1800 is shown in FIG. 16.The catheter 1800 may be similar to the catheters 1600, 1700 of FIGS.14-15, but may include a circulating pump 1852. The circulating pump1852 may receive a lavage fluid from a drainage lumen of the catheter1800 and then circulate that fluid back to a body cavity through aninjection lumen. This embodiment may be advantageous where it isdesirable to circulate a medication through a particular area of a bodycavity multiple times. Further, the fluid circulated through thecatheter 1800 may be a suitable mixture of medication and body fluid orsaline with a suitable concentration of the medication. It iscontemplated that the circulating pump 1852 may be programmed to turn onand off automatically such that an appropriate number of lavagetreatments are performed and such that each lavage treatment isperformed for an appropriate amount of time. The circulation pump mayoptionally include filtration elements up to and including highlyselective filters such as used in various dialysis machines, physicallyand/or chemically selective-binding elements, and/or other elementsconfigured to remove, replace, and/or add in predetermined materialsfrom/to the fluid and/or fluid-borne mixture. It is contemplated thatthe circulating pump 1852 may be controlled by the patient and/or themedical professional. In some embodiments, the circulating pump 1852 maybe associated with a sensor that provides feedback to a pump controller.

Herein, the embodiments of a dual lumen indwelling catheter areprimarily described as intended for operation in the pleural cavity, butthe present disclosure also covers catheters associated with other bodycavities. Two non-limiting examples are shown in FIGS. 17A-17B.Referring to FIG. 17A, a catheter 1900 may be deployed in the peritonealcavity 1966. Like many of the other embodiments described above, thecatheter 1900 may include a first distal tube portion 1940 configuredprimarily for the injection of a fluid (e.g., a medication) and a seconddistal tube portion 1942 configured primarily for drainage. The catheter1900 may include a first proximal tube portion 1908 with a port 1950that remains under the skin of a patient and a second proximal tubeportion 1910 that extends externally from the body of the patient whendeployed. A cuff element 1922 may be located on the second proximal tubeportion 1910, as shown.

Referring to FIG. 17B, a dual lumen catheter 2000 may be associated withan organ 2068 (e.g., a bladder). The catheter 2000 may have a bifurcatedlength with the first and second proximal tube portions 2008 and 2010configured respectively for injection and drainage, for example, andrespectively associated with an injection lumen 2002 and drainage lumen2004. A binal portion 2014 may extend distally from the proximal tubeportions to and beyond a sealing element 2022 and into the organ 2068.It is contemplated that a seal may be created where the binal portion2014 enters the organ 2068. For example, when the organ 2068 is aurinary bladder, it may be necessary to provide a second and/or furtherplural sealing element(s) at the entry location of the bladder 2068 suchthat fluid from within the bladder does not leak to other areas of thepatient body. The catheter 2000 is depicted without a bifurcated distalend, but this is not required. As shown, injected fluid may becirculated through the organ 2068 by injecting through the injectionlumen 2002 and draining through the drainage lumen 2004 simultaneously(or seriatim, in this and other embodiments).

FIG. 18 shows an embodiment of a dual lumen indwelling catheter withseparable or splittable tube portions. Referring to FIG. 18, thecatheter 2100 may include a proximal bifurcated length 2106, a distalbifurcated length 2107, and a binal portion 2114 therebetween. The binalportion 2114 of the catheter 2100 may have a first lumen 2102 and asecond lumen 2104 that are separable or splittable. For example, thefirst lumen 2102 and the second lumen 2104 may be connected via arelatively weak connection such that they can be pulled apart by amedical professional. When this occurs at the proximal end of the binalportion 2114, the length of the proximal bifurcated length 2106 mayincrease and the length of the binal portion 2114 may decrease.Similarly, when this occurs at the distal end, the bifurcated distalbifurcated length 2107 may increase and the length of the binal portion2114 may decrease. Advantageously, the catheter 2100 may therefore havedimensions that are adjustable to a particular medical procedure in aparticular patient. For example, the catheter 2100 of FIG. 18 may bemodified by a medical professional just before deployment rather than ina manufacturing facility.

Further, as depicted by FIG. 18, the bifurcated tube portions of theproximal bifurcated length 2106 may have different lengths (and,similarly, the lengths of the tube portions of the distal bifurcatedlength 2107 may be different). The lengths of these tube portions may beoptimized for certain conditions and functions. For example, when a tubeportion is associated with a port that may remain under the skin, it maybe short with respect to a tube portion that will extend externally froma patient body. Similarly, a tube portion that must extend to arelatively remote location within a body cavity may be relatively longwhen compared to an internal tube portion. The length of the tubeportions may be formed during the manufacturing of the catheter 2100. Itis also contemplated that a medical professional may have the ability tocut one or more of the tube portions to an appropriate length before orduring the deployment of the catheter 2100 (which may require attachingcertain components, such as a valve and/or a port, after cutting thetube portions to length).

During an injection and/or drainage procedure, a variety of actions maybe used to provide a desirable distribution of a drug. For example, itis contemplated that an internal portion of a catheter disclosed hereinmay be configured to vibrate or otherwise move during injection, and/ora device may be utilized to vibrate the patient's body (e.g., avibrating chair). Additionally or alternatively, a pump connected to aninjection lumen may provide a pulsing injection pressure, and/or avacuum force associated with a drainage lumen may pulse. Injection maybe continuous for a long period of time, or not. In some circumstances,it may be advantageous to use a single-use disposable pump designed todeliver (and/or drain) a precise amount of a medication or other fluid.A drug may be injected for minutes, hours, or days, followed by laterdrainage (or, alternatively, drainage can occur during or even beforeinjection). Further, different drug types may be injected in aparticular sequence. Injected drugs may be solid or liquid (includinghydrogel) and may be heated or cooled. A sensor may be associated withthe indwelling catheter to measure a parameter (such drug concentrationin the body or in a drained fluid, for example), which may providefeedback to the patient, a medical professional, and/or an automaticsystem.

The embodiments disclosed herein may be advantageous for providing theability to perform a variety of medical procedures. For example, a duallumen indwelling catheter as described herein may provide the ability toinject a medication, such as a cancer-treating chemotherapy drug, into abody cavity and then remove that same medication before it can causesubstantial damage to surrounding healthy tissue. This injection may beaccomplished without surgery and it may be repeatable. Accordingly, thedose of medication may be optimized in view of the ability to repeat theprocedure. It is also contemplated that the disclosed device could beutilized for other local treatments, such as localized antibioticapplication, intentional introduction of chemical pleurodesis,immunotherapy or biologic therapy, or any other suitable procedureinvolving the introduction and/or the removal of fluid or othersubstances.

Those of skill in the art will appreciate that embodiments not expresslyillustrated herein may be practiced within the scope of the presentinvention, including features described herein for different embodimentsmay be combined with each other and/or with currently-known orfuture-developed technologies while remaining within the scope of theclaims presented here. For example, the various physical structuresdisclosed may also provide mechanical irritation promoting a desiredsclerotic effect, and the structures and components disclosed herein maybe combined with each other or other features. Although specific termsare employed herein, they are used in a generic and descriptive senseonly and not for purposes of limitation. It is therefore intended thatthe foregoing detailed description be regarded as illustrative ratherthan limiting. And, it should be understood that the following claims,including all equivalents, are intended to define the spirit and scopeof this invention. Furthermore, the advantages described above are notnecessarily the only advantages of the invention, and it is notnecessarily expected that all of the described advantages will beachieved with every embodiment of the invention.

1-20. (canceled)
 21. A catheter comprising: a distal portion comprising:a first lumen extending longitudinally through a lengthwise portion ofthe distal length, the first lumen at least partially defined by a firstinner diameter surface of the distal portion; and a second lumenextending longitudinally through the lengthwise portion of the distallength, the second lumen at least partially defined by a second innerdiameter surface of the distal portion; a proximal portion comprisingthe first lumen and the second lumen; and a binal portion between thedistal portion and the proximal portion having a single outer wall,wherein the binal portion comprises the first lumen and the second lumenthat are both enclosed by a same outer perimeter of the single outerwall; wherein the binal portion has a non-circular cross sectional shapewith a relatively narrow portion comprising the first lumen and arelatively wide portion comprising the second lumen.
 22. The catheter ofclaim 21, wherein the proximal portion includes a bifurcated lengthhaving a first tube portion and a second tube portion, wherein the firstlumen extends longitudinally through the tube first portion, and whereinthe second lumen extends longitudinally through the second tube portion.23. The catheter of claim 22, wherein the first tube portion includes afirst valve configured for an injection procedure, and wherein thesecond tube portion includes a second valve configured for a drainageprocedure.
 24. The catheter of claim 21, wherein a distal end of thedistal portion includes the first lumen with a plurality offenestrations spaced longitudinally, wherein the space between thefenestrations decreases closer to a distal terminus.
 25. The catheter ofclaim 21, wherein a distal end of the distal portion includes the firstlumen with a plurality of fenestrations spaced longitudinally, wherein across-sectional size of the fenestrations increases closer to a distalterminus.
 26. The catheter of claim 21, wherein the distal portionincludes a bifurcated length having a first distal tube portion and asecond distal tube portion, wherein the first lumen extends through thefirst distal tube portion and the second lumen extends through thesecond distal tube portion.
 27. The catheter of claim 21, wherein thediameter of the second lumen is at least two (2) times as large as thediameter of the first lumen.
 28. The catheter of claim 21, wherein theproximal length includes a first proximal tube portion that includes aninjection port.
 29. A catheter comprising: a bifurcated distal portioncomprising a first distal tube portion and a second distal tube portion;a bifurcated proximal portion comprising a first proximal tube portionand a second proximal tube portion; a binal portion between thebifurcated distal portion and the bifurcated proximal portion having asingle outer wall; wherein a first lumen extends through the firstdistal tube portion, the first proximal tube portion and the binalportion, and a second lumen extends through the second distal tubeportion, the second proximal tube portion and the binal portion, thebinal portion has a non-circular cross sectional shape with a relativelynarrow portion comprising the first lumen and a relatively wide portioncomprising the second lumen.
 30. The catheter of claim 29, wherein thefirst proximal tube portion includes a first valve configured for aninjection procedure, and wherein the second proximal tube portionincludes a second valve configured for a drainage procedure.
 31. Thecatheter of claim 29, wherein at least one of the first and seconddistal tube portions includes a plurality of fenestrations spacedlongitudinally, wherein the space between the fenestrations decreasescloser to a distal terminus.
 32. The catheter of claim 29, wherein atleast one of the first and second distal tube portions includes aplurality of fenestrations spaced longitudinally, wherein across-sectional size of the fenestrations increases closer to a distalterminus.
 33. The catheter of claim 29, wherein the diameter of thesecond lumen is at least two (2) times as large as the diameter of thefirst lumen.
 34. The catheter of claim 29, wherein the first proximaltube portion includes an injection port.
 35. A method of removing bodilyfluid while delivering a medicament using a catheter for heatedintraperitoneal chemoperfusion, the method comprising: placing abifurcated distal portion of the catheter into a cavity of a patientbody, the catheter comprising: the bifurcated distal portion comprisinga first distal tube portion and a second distal tube portion; abifurcated proximal portion comprising a first proximal tube portion anda second proximal tube portion; and a binal portion between thebifurcated distal portion and the bifurcated proximal portion having asingle outer wall; wherein a first lumen extends through the firstdistal tube portion, the first proximal tube portion and the binalportion, and a second lumen extends through the second distal tubeportion, the second proximal tube portion and the binal portion, thebinal portion having a non-circular cross sectional shape with arelatively narrow portion comprising the first lumen and a relativelywide portion comprising the second lumen; moving a bodily fluid withinthe cavity of the patient body from external the second lumen tointernal the second lumen through a fenestration in the second distaltube portion; and moving the bodily fluid proximally within the secondlumen of the second proximal tube portion located outside the patientbody; moving a medicament distally within the first lumen from the firstproximal tube portion located outside the patient body to the firstdistal tube portion located inside the patient body; and discharging themedicament from the first distal tube portion into the cavity.
 36. Themethod of claim 35, wherein the first proximal tube portion includes afirst valve configured for an injection procedure, and wherein thesecond proximal tube portion includes a second valve configured for adrainage procedure.
 37. The method of claim 35, wherein at least one ofthe first and second distal tube portions includes a plurality offenestrations spaced longitudinally, wherein the space between thefenestrations decreases closer to a distal terminus.
 18. The method ofclaim 35, wherein at least one of the first and second distal tubeportions includes a plurality of fenestrations spaced longitudinally,wherein a cross-sectional size of the fenestrations increases closer toa distal terminus.
 19. The method of claim 35, wherein the diameter ofthe second lumen is at least two (2) times as large as the diameter ofthe first lumen.
 20. The method of claim 35, wherein the first proximaltube portion includes an injection port.